Within the pharmaceutical industry, drug portfolios are evolving towards more structurally complex biotechnology drugs, which puts more pressure on the supply chain. Though vaccines are one important part of this, they are not the only high priority item that relies heavily on cold chain logistics.
Gene therapy, which is the removal or change in the content of a patient’s genetic code with the goal of treating or curing a disease, is an intricate and delicate process. Uncountable hours of scientific research are needed to develop these genes and to identify the best means of delivery, as the finished products require stringent temperature controls and are viable only for a short space of time.
For example, with autologous therapies, where cells from transplants come from the person receiving the transplant, biological material must be collected directly from the patient and transferred to the manufacturing site. The modified, personalized therapy is then shipped back to be administered to the patient.
The complexity of managing this process is immense. These patients could be based anywhere in the world, which means a challenging collection process may be required. Both the patient cells and therapy must also be shipped using liquid nitrogen or under refrigerated conditions and typically must arrive within 40–50 hours. Strict temperature monitoring is critical throughout and careful understanding of regulations is also required. A single error at any point can have costly implications for both the clinical trial sponsors and the patients involved.
With the huge amount of work and vast amounts of money that is invested into harvesting and synthesizing these cells, the same effort must be reciprocated in how they are stored, kept safe and ready to move to the patient.
The same is true when it comes to the other side of the gene therapy coin, allogenic gene therapy, where large batches of drugs are developed from unrelated donor tissues and used to treat hundreds or thousands of patients.